Dual Expanding Palatal Distractor

ABSTRACT

An orthodontic distractor includes two rods connected so as to be spread apart are brought together at either end. Also, a first coupling assembly is configured to couple the first rod to a bicuspid and a molar tooth of a patient and a second coupling assembly is configured to couple the second rod to a bicuspid and a molar tooth of a patient. Also, the first coupling assembly includes first extension arms attached to the first rod so as to permit adjustment of a vertical angle between said first rod and said first extension arms, and the second coupling assembly comprises second extension arms coupled to the second rod, so as to permit adjustment of a vertical angle between said first rod and said first extension arms.

CROSS-REFERENCE TO RELATED APPLICATION

This application is continuation-in-part of application Ser. No.15/076,441 filed on Mar. 21, 2016 and claims the benefit of U.S.Provisional Patent Application No. 62/113,5467, filed Mar. 19, 2015,which are incorporated herein by reference in their entirety.

BACKGROUND

Orthodontists and dental researchers are constantly searching for newand improved ways to correct the problem of upper jaw constriction withcollapsed dental arch causing lingual cross bites or overly wide upperjaw and dental arch causing buccal posterior cross bites.

Posterior cross bites are the most common dental malocclusion in youngor adult patients due to various etiologies. The condition due toinsufficient maxillary arch width in various dimensions can causefurther skeletal growth problems if left untreated. The overgrown widthof the upper jaw also by causing buccal cross bite can cause significantdamage to the dentition and growth of the temporomandibular joints.Expansion of the maxilla relies on rapid palatal expander devices thatdeliver forces to break the mid-palatal and circum-maxillary sutures tofacilitate transverse and sagital dento-facial correction.

Current orthodontic devices for spreading the jaws, dental arches, orcontracting the dental arches have not been entirely satisfactorybecause such devices are capable of performing only one of parallelexpansion, parallel contraction, fan shape expansion, or fan shapecontraction of the jaws and dental arches. Current expansion appliancessuch as HYRAX (tooth borne) and HAAS expander (tooth and tissue borne)designs are limited to transverse bilateral and parallel expansion inthe posterior region of the maxilla. As a result, they lack thedifferential nonparallel expansion or contraction capability unlesssequentially used in combination with fan shape design expanders. As aresult, in most cases with V-shape maxillary arch forms (wider in theback than front), during the expansion of the premolar or caninesections to proper width, the molar areas can get over-expanded, causingbuccal cross bite in the molar areas. This impact can be opposite insignificant V-shape maxillary constriction, causing the premolar andcanine teeth end up in over-extend or buccal cross bite as the molarareas are expanded to the ideal width.

SUMMARY

Embodiments of expander devices described herein provide improvedorthodontic appliances and protocol for expanding or contracting thejaws and dental arches as well as enlarging the nasal cavity and upperpharyngeal airway.

This palatal expander design gives the clinician the ability to directexpansion or constriction forces to various segments of the maxillaryarch in nonparallel configuration.

In some embodiments described herein, expander devices provide an archspreading or contracting device and protocol that is simple in structureand use, that avoids the defects and insufficiencies of the presentlyavailable devices, and that, at the same time, are capable ofdifferential nonparallel expansion or contraction of the jaws and dentalarches.

In some embodiments described herein, expander devices provide a Jaw anddental arch spreading capability that not only addresses the dentitionand the jaw bones, but also reshapes and expands the nasal cavity andpalatal soft tissue, as well as enlarging the nasal airway and behindthe soft palate airway (retropalatal). This can be accomplished byenlarging the mouth and accommodating the position of the tongue forwardout of the pharynx, and by enlarging the airway behind the tongue(retroglossal) and below and behind the tongue (hypoglossal). This willcontribute in enlarging the nasopharyngeal airway by expanding theenvironment of the upper airway starting from nostrils, nasal cavityretropalatal area, retroglossal area, and hypoglossal area.

In a first separate aspect, the present invention may take the form ofan orthodontic distractor capable of expansion or constriction to adjustthe position of one or more of a patient's upper teeth, jaws, oralcavity and airway. The distractor includes an adjustable assembly thathas a first rod and a second rod, each of the first and second rodshaving a first end and a second end, wherein each of the first andsecond rods is couplable to upper teeth of a patient. A mechanismjoining the first and second rods and permitting the first ends of thefirst and second rods to be pushed apart or pulled together independentof the second ends and which permits the second ends of the first andsecond rods to be pushed apart or pulled together independent of thefirst ends. First and second coupling assemblies are configured tocouple the first rod to a bicuspid and a molar tooth of a patient andboth coupling assemblies includes extension arms attached to the rod soas to permit adjustment of a vertical angle between said rod andextension arm.

In a second separate aspect, the present invention may take the form ofan orthodontic distractor capable of expansion or constriction to adjustthe position of one or more of a patient's upper, lower teeth, jaws,oral cavity and airway. the distractor includes a screw assembly, thathas a first rod and a second rod, each of the first and second rodshaving a first end and a second end, wherein each of the first andsecond rods is couplable to one or more of upper teeth and palatal bonesof a patient; a plurality of rotatable head members, each of whichcomprises a threaded hole, wherein the plurality of rotatable headmembers comprises a first rotatable head member connected to the firstend of the first rod, a second rotatable head member connected to thefirst end of the second rod, a third rotatable head member connected tothe second end of the first rod, and a fourth rotatable head memberconnected to the second end of the second rod, wherein the threadedholes of the first and second rotatable head members are of oppositehand, and wherein the threaded holes of the third and fourth rotatablehead members are of opposite hand; a first twin screw having threadedends of opposite hand, wherein the threaded ends of the first twin screware configured to engage the threaded holes of the first and secondrotatable head members such that rotation of the first twin screw causesthe first and second rotatable head members and the first ends of thefirst and second rods to either move together or move apart; and asecond twin screw having threaded ends of opposite hand, wherein thethreaded ends of the second twin screw are configured to engage thethreaded holes of the third and fourth rotatable head members such thatrotation of the second twin screw causes the third and fourth rotatablehead members and the second ends of the first and second rods to eithermove together or move apart; a first coupling assembly configured tocouple the first rod to one or more of upper teeth and palatal bones ofa patient; and a stabilizing member placed between said first and secondrod and extending between and engaged to said first twin screw and saidsecond twin screw so as to constrict movement of both said first twinscrew and said second twin screw and maintain said first and second twinscrews in parallel orientation.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This summary is not intended to identify key features ofthe claimed subject matter, nor is it intended to be used as an aid indetermining the scope of the claimed subject matter.

DESCRIPTION OF THE DRAWINGS

The foregoing aspects and many of the attendant advantages of thisinvention will become more readily appreciated as the same become betterunderstood by reference to the following detailed description, whentaken in conjunction with the accompanying drawings, wherein:

FIG. 1 shows a bottom view of a palatal distractor according to a firstrepresentative embodiment of the present disclosure, wherein the palataldistractor is installed on the upper palate of a patient;

FIG. 2 shows a partial bottom view of the distractor of FIG. 1;

FIG. 2A is a partial bottom view of an alternative embodiment of adistractor;

FIG. 2B is a partial bottom view of another alternative embodiment of adistractor;

FIG. 3 show an isometric view of a screw assembly of the distractor ofFIG. 1;

FIG. 4 shows a partial cross-sectional view of the screw assembly ofFIG. 3;

FIG. 5 shows a second partial cross-sectional view of the screw assemblyof FIG. 3;

FIG. 6 shows a bottom view of a palatal distractor according to a secondrepresentative embodiment of the present disclosure, wherein the palataldistractor is installed on the upper palate of a patient;

FIG. 7 shows a bottom view of a palatal distractor according to a thirdrepresentative embodiment of the present disclosure;

FIG. 8 shows a bottom view of the palatal distractor of FIG. 7, whereinthe palatal distractor is installed on the upper palate of a patient;

FIG. 9 shows a bottom view of a palatal distractor according to a fourthrepresentative embodiment of the present disclosure, wherein the palataldistractor is installed on the upper palate of a patient;

FIG. 10 shows a partial cross-sectional view of the distractor of FIG.9;

FIG. 11 shows an isometric view of a maxillary jaw dental arch accordingto a fifth representative embodiment of the present disclosure;

FIG. 12 shows a bottom view of the maxillary jaw dental arch of FIG. 11;

FIG. 13 shows a bottom view of the screw assembly of FIG. 3 with thedirections of forces which may be exerted on the teeth and differentareas of the upper jaw and airway by the distractor and around thecenters of rotation; and

FIG. 14 shows a method of treating a patient using a palatal distractor.

DETAILED DESCRIPTION

The detailed description set forth below in connection with the appendeddrawings, where like numerals reference like elements, are intended as adescription of various embodiments of the present disclosure and are notintended to represent the only embodiments. Each embodiment described inthis disclosure is provided merely as an example or illustration andshould not be construed as precluding other embodiments. Theillustrative examples provided herein are not intended to be exhaustiveor to limit the disclosure to the precise forms disclosed. Similarly,any steps described herein may be interchangeable with other steps, orcombinations of steps, in order to achieve the same or substantiallysimilar result. Likewise, unless otherwise noted, any steps describedherein are not limited to a particular order, such that steps may berearranged in some instances to achieve the same or substantiallysimilar result.

In the following description, specific details are set forth to providea thorough understanding of exemplary embodiments of the presentdisclosure. It will be apparent to one skilled in the art, however, thatthe embodiments disclosed herein may be practiced without embodying allof the specific details. In some instances, well-known process stepshave not been described in detail in order not to unnecessarily obscurevarious aspects of the present disclosure. Further, it will beappreciated that embodiments of the present disclosure may employ anycombination of features described herein.

The present application may include references to directions, such as“forward,” “rearward,” “upper,” “lower,” “left,” “right,” etc. Thesereferences, and other similar directional references in the presentapplication, are only to assist in helping describe and to understandthe particular embodiment and are not intended to limit the presentdisclosure to these directions or locations.

The following discussion provides examples of methods and orthodonticapparatuses that include a screw device for stretching or contracting apatient's dental arches sideward or inward horizontally, expanding theupper jaw bone, as well as enlarging the palate, oral cavity, nasalcavity and upper nasopharyngeal airway. This expander design gives theclinician the ability to direct expansion or constriction forces tovarious segments of the dental arches, and expansion of maxillary jaw aswell as nasal cavity in nonparallel configuration.

One purpose of the apparatuses described herein is to provide anexpansion and constriction screw apparatus which can be used inmultipurpose manner to not only expand the front and back teeth andsections of the upper jaw and nasal cavity in nonparallel ways intransverse directions, respectively, but also to effectively constrictthe maxillary dental arch front and back teeth.

This purpose is achieved, in some embodiments, by connecting respectiveends of rods rotatable head members with a threaded hole where thethreads of the threaded holes are of opposite hand on each side, and byproviding a twin screw on respective ends of the rods which is inthreaded engagement with the threaded holes of the rotatable headmembers attached to the each ends of the rods. The twin screw assemblyof this design makes it possible to exert independent, nonparallel,transverse expansion and constriction forces on the front and/or backteeth.

In some embodiments, the adjustable twin screw assemblies are embeddedin mirror image extension plates, the separate parts of which are formedto fit against teeth and supporting soft palate on opposite sides of theupper jaw, with the plates being separated sufficiently to enable thetwin screw assemblies to fit between them and to thereby adjust therelative positions of the two plate parts.

Referring to FIGS. 1-5, a first embodiment of a palatal distractor 50will now be described. The distractor includes a screw assembly 60 thatis coupled to one or more upper teeth and/or palatal bones of a patientby a pair of coupling assemblies 300, 400. As best shown in FIGS. 2 and3, the screw assembly includes a first rod 100 and a second rod 200coupled to each other by a first screw 70 and a second screw 80. In theillustrated embodiment the second rod 200 is a mirror image of the firstrod 100. For the sake of brevity, the first rod 100 will be describedherein with the understanding that the second rod 200 is similar to thefirst rod, and a component of the second rod with a reference number 2XXcorresponds to a similar component 1XX of the first rod.

The first rod 100 includes a central body section 100 with a firstclevis 104 disposed at a first end, and a second clevis 106 disposed ata second end. The first and second clevises 104 and 106 are illustratedas being integrally formed with the central body section 100; however,embodiments are contemplated in which the clevises are formed separatefrom the central body section and then attached by known fasteners,adhesives, or other means. Further embodiments are contemplated in whichthe distance between the clevises 104 and 106 is adjustable. In thisregard, one or both clevises 104 and 106 can be configured to slidinglyengage the central body section 100 and then selectively positioned andsecured in place. This and other embodiments that enable adjustment ofthe clevis positions are contemplated and should be considered withinthe scope of the present disclosure.

A first rotatable head member 120 is positioned between the arms of thefirst clevis 104. Trunnions 122 extend from opposing sides of the firstrotatable head member 120, and each trunnion is received within a holeformed in one of the arms of the first clevis 104. In this manner, thefirst rotatable head member 120 is rotatably mounted to the first clevis104 about an axis that passes through the center of the trunnions 122.At the other end of the rod 100, a second rotatable head member 124 hastrunnions 126 extending from opposite sides to rotatably mount thesecond rotatable head member to the second clevis 106 in a mannersimilar to the mounting of the first rotatable head member 120 to thefirst clevis 104. Each of the rotatable head members 120 and 124 isrespectively provided with threaded to threadedly engage the first end72 and 82 of first and second twin screws 70 and 80, respectively.

The first twin screw 70 has a first end 72 with threads formed thereon.The first end 72 of the first twin screw 70 threadedly engages thethreaded hole formed in the first rotatable head member 120 of the firstrod 100. A second end 74 of the first twin screw 70 also has threadsformed thereon, wherein the threads of the first end 72 are of theopposite hand of the threads of the second end. The second end 74 firsttwin screw 70 is threadedly engaged with the threaded hole formed infirst rotatable head member 220 of the second rod 200. Thus, rotation ofthe first twin screw 70 in a first direction moves the first rotatablehead members 120 and 220, and therefore, the first ends of the first andsecond rods 100 and 200, away from each other. Conversely, rotation ofthe first twin screw 70 in a second direction moves the first rotatablehead members 120 and 220, and therefore, the first ends of the first andsecond rods 100 and 200, towards each other.

The middle portion of the first twin screw 70 includes a fitting 76provided with two through-and-through openings 78 positionedperpendicular to each other.

The first twin screw 70 can be rotated by means of a tool inserted intoone of the crossed openings 70. Other possible embodiments of thefitting 76 include flats formed on the fitting to allow a wrench toengage the flats to facilitate rotation of the first twin screw 70.These and other features that enable rotation of the first twin screw 70are contemplated and should be considered within the scope of thepresent disclosure.

The second twin screw 80 is similar to the first twin screw 70, havingfirst and second ends 82 and 84 that are threaded so that the threads ofone end are of the opposite hand of the threads of the other end. Thethreaded ends 82 and 84 threadedly engage the second rotatable headmembers 124 and 224, respectively, so that rotation of the second twinscrew 80 in a first direction moves the second rotatable head members124 and 224, and therefore, the second ends of the first and second rods100 and 200, away from each other. Conversely, rotation of the secondtwin screw 80 in a second direction moves the second rotatable headmembers 124 and 224, and therefore, the second ends of the first andsecond rods 100 and 200, towards each other.

In a further embodiment of a palatal distractor 50′ shown in FIG. 2A, astabilizing element 330 is placed between rods 100 and 200, and so thatit straddles screws 70 and 80, thereby maintaining screws 70 and 80 inparallel orientation. This provides stability that may be lacking whenelement 330 is absent. A first end of element 330 defines a first pairof apertures 332 and a second end of element 330 defines a second pairof apertures 334, through which, respectively pass screws 70 and 80.

In yet a further embodiment of a palatal distractor 50″, shown in FIG.2B, a stabilizing element 330′ is placed in similar arrangement toelement 330 for distractor 50′. Stabilizing element 310′ defines a firstpair of saddles 332′ and a second pair of saddles 334′, as opposed toapertures, which similarly constrict the movement of screws 70 and 80,thereby providing enhanced stability to distractor 50″.

In both embodiments 50′ and 50″, arms 310′, 312′, 410′ and 412′ mayterminate in much the same manner as arms 310, 312, 410 and 412 ofembodiment 50. In another alternative embodiment, the proximal portionof arms 310′, 312′, 410′ and 412′ are identical to 310, 312, 410 and414, with the only difference between the embodiments 50, 50′ and 50″being the addition of a stabilizing element 330′ or 330″.

Referring now to FIGS. 1, 2 and 4, a first coupling assembly 300 couplesthe first rod 100 to the upper right bicuspid 20 and molar 22. The firstcoupling assembly 300 includes a base 302 that has an L-shaped crosssection. The base 302 is sized to fit within the slot 108 formed in thebody 102 of the first rod 100. Set screws 110 and 112 extend from anoutside surface of the body 102 into the cavity 108. As best shown inFIG. 4, the set screws engage a flat portion 322 of the base 302 topress the base against one side of the slot 108, thereby maintaining theposition of the base, and therefore, the coupling assembly 300, relativeto the first rod 100. A leg 230 of the base extends away from the flatportion 322 and is positioned so that the leg will engage the set screws110 and 112 to prevent the base from disengaging with the first rod 100unless the set screws are first loosened or removed.

Referring back to FIG. 1, the coupling assembly 300 includes extensionarms 310 and 312 extending outward from the base 302 and connected by across-member 318. A bicuspid band 314 is coupled to one of the extensionarms 310 and is sized and configured to be fitted on a bicuspid 20. Amolar band 316 is couple do the other extension arm 312 and is sized andconfigured to be fitted on a molar 22. With the bicuspid band 315 andthe molar band 316 secured to the bicuspid 20 and molar 22,respectively, the first rod is fixedly secured to one side of the mouthof the patient.

In the illustrated embodiment, the second coupling assembly 400 is amirror image of the first coupling assembly, wherein a component of thesecond coupling assembly having a reference number of 4XX corresponds toa component from the first coupling assembly 300 having a referencenumber of 3XX. It will be appreciated that the disclosed couplingassemblies are exemplary only and should not be considered limiting. Inthis regard, various other embodiments are contemplated, whereindifferent configurations are provided to couple the screw assembly 60 tothe patient's teeth, palatal bones, or a combination thereof. Moreover,various configurations are contemplated in which one coupling assemblyis not a mirror image of the other coupling assembly, for example, if apatient is missing one or more teeth or has other oral asymmetries.

The use of the slotted configuration to couple base 302 to the first rod100 allows for adjustment of the coupling assemblies 300 and 400relative to the screw assembly 60. That is, the coupling members 300 and400 can be located relative to the teeth/palatal bones, and then the setscrews can be tightened to lock the position of the coupling assembliesto the screw assembly 60. The adjustability of the coupling members 300and 400 in combination with the nonparallel expansion capability makesthe screw assembly 60 provides a distractor that is easily adjustable tothe patient. The appliance does not need to be pre-adjusted but can beadjusted by a clinician right after the opening the packaging. Also,such a device does not require prefabrication.

Referring to FIGS. 3 and 5, the first rod 100 further includes aplurality of apertures 114 extending there, though to allow the firstrod to be secured directly to the palate of the patient using screws orother suitable fasteners. As best shown In FIG. 5, each aperture 114 hasa counterbore 150 formed at the upper end. A screw 140 has a head 142, ashaft 146, and a threaded portion 148. The head 142 of the screw 140 islarger than the diameter of the aperture 114 and is received within thecounterbore 150. The threaded portion 148 of the screw 140 is largerthan the diameter of the aperture 114. As a result, when the screw 140is inserted in the aperture, the body 102 of the first rod 100 isretained between the head 142 and the threaded portion 148. It will beappreciated that the screws 140 can be used in addition to or in lieu ofthe coupling member 300.

When the screw assembly 60 is directly coupled to a patient's palateusing screws 140, the position of the screw assembly is determined bythe depth of the screws. This prevents the application of undue pressureto the palate by the screw assembly when the screws are tightened.Further, the inclusion of multiple holes on each end of each rod 102 and104 allows a screw assembly to be secured to the palate while leaving atleast one aperture 114 on each end of each rod unused. When the screwassembly 60 is removed and reinstalled, alternate holes can be used.This allows the previous insertion location of the screw to heal whilean alternate screw location is used to secure the screw assembly to thepalate. In some embodiments, the screws mentioned above will be used asmain attachment of the expander to the roof of the patient's mouth withno other means for attachment to the teeth in cases that the patient ispartially or fully edentulous with no teeth or teeth that cannot supportthe force of applied forces from expansion or distraction.

An advantage of embodiments of the dual expander design type screw andorthodontic appliance assembly is that it is possible to select anydesired variation of transverse extension and/or constriction at thefront and back teeth using one appliance. FIG. 13 shows the directionsof forces which may be exerted on the teeth and different areas of theupper jaw and airway and around the centers of rotation CR1, CR2 of thescrew assembly 60. Transverse expansion force (TE) and transversecontraction force (TC) are achieved by rotating the first and secondtwin screws 70 and 80 by equal amounts, thereby maintaining the angularposition of the first and second rods 100 and 200 relative to eachother. Rotational forces R1 and R2 are achieved turning the first twinscrew 70 and the second twin screw 80 asymmetrically so that the angularposition of the first and second rods 100 and 200 changes relative toeach other.

FIG. 6 shows a first alternate embodiment of a palatal distractor 52according to the present disclosure. The distractor includes screwassembly 60 as previously described. Coupling assemblies 500 and 600attached the screw assembly 60 to the mouth of the patient. In theillustrated embodiment, the second coupling assembly 600 is a mirrorimage of the first coupling assembly 500, wherein a component of thesecond coupling assembly having a reference number of 6XX corresponds toa component from the first coupling assembly 500 having a referencenumber of 5XX. The first coupling assembly 500 will be described hereinwith the understanding that unless otherwise noted, the second couplingassembly 600 is a mirror image of the first coupling assembly.

The coupling assemblies 500 and 600 include left and right halves 504and 604, respectively, of two-part acrylic palate plate custom fitted tothe patient's palate. The left half 504 and a right half 604 of thepalate plate are symmetrical in the disclosed embodiment; however,alternate embodiments are contemplated wherein the halves areasymmetrical.

Parts of the first ends of the first and second twin screws 70 and 80are embedded in the right acrylic palatal plate 604. Parts of the firstends of the first and second twin screws 70 and 80 are embedded in theleft acrylic palatal plate 504. Thus, the screw assembly 60 maintainsthe position of the left and right palatal plates 504 and 604 relativeto each other. When in place, the plates 504 and 604 extend from theanterior portion of the palate behind the incisors, approximately inline with the mesial side of the first bicuspids to the posteriorportion of the palate approximately in line with the mesial side of thesecond molars.

The first coupling assembly 500 includes a mounting fitting 506 coupledto the screw assembly 60 in a manner similar to the previously describedembodiment. Alternate embodiments are contemplated in which the mountingfitting 506 is coupled to the left palatal plate 504 or a combination ofthe screw assembly 60 and the left palatal plate. The illustratedembodiment further includes a molar band 508 for securing the mountingfitting 506 to a molar 22. The first coupling assembly also includes anocclusal rest arm 510 securable to the bicuspid 20 by adhesive cement orother suitable means.

Alternate embodiments are contemplated in which various combinations ofbands and rest arms are utilized. For example, molar bands and bicuspidbands can be utilized. In addition, occlusal rest arms and lingual restarms can be secured to various teeth using adhesive cement or othersuitable means. These and other configurations for securing appliancesto teeth, both alone or in combination with each other, are contemplatedand should be considered within the scope of the present disclosure.

In some embodiments, the appliance includes plates or rods which arepre-made or custom fitted to the occlusal or lingual surface of theright or left first and second bicuspids and extend to the occlusal orlingual surface of right and left first or second molars. Each left andright plates or rods are securable to the patient's occlusal or lingualsurface of the left and right upper first or second bicuspids and firstor second molars by adhesive cement.

FIGS. 7 and 8 show a second alternate embodiment of a palatal distractor54 according to the present disclosure. The distractor includes screwassembly 60 as previously described. Coupling assemblies 700 and 800attached the screw assembly 60 to the mouth of the patient. In theillustrated embodiment, the second coupling assembly 800 is a mirrorimage of the first coupling assembly 700, wherein a component of thesecond coupling assembly having a reference number of 8XX corresponds toa component from the first coupling assembly 700 having a referencenumber of 7XX. The first coupling assembly 700 will be described hereinwith the understanding that unless otherwise noted, the second couplingassembly 800 is a mirror image of the first coupling assembly.

As shown in FIG. 7, the first coupling assembly 700 is similar topreviously described first coupling assembly 300, having a base 702, andfirst and second extension arms 704 and 706 extending therefrom. Abone-borne plate 708 is coupled to the extension arms 704 and 706 andhas a plurality of insertion studs 710 disposed on the outer surface ofthe bone-borne plate for securing and attaching the plate in a patient'spalatal bones bilaterally. FIG. 8 shows a variation of the embodiment ofFIG. 7 in which the fasteners 716 and 718 are used in addition to or inlieu of the insertion studs 710 to secure the plate 714 to the patient'sbones.

This bone-borne option can eliminate the need of orthodontic bands onmolars and premolars and is an effective system for children at earlymixed dentition with primary teeth or missing teeth in transitionalstage of dental development who have upper jaw and arch constriction,excessive upper arch expansion, cross bite (unilateral/bilateral),and/or severe upper airway constriction. This bone-borne embodiment mayneed surgical intervention for insertion of the appliance into thepatient's mouth under sedation and local anesthesia.

FIGS. 9 and 10 show a third alternate embodiment of a palatal distractor56. The distractor 56 includes screw assembly 60 as previouslydescribed. Coupling assemblies 900 and 1000 attached the screw assembly60 to the mouth of the patient. In the illustrated embodiment, thesecond coupling assembly 1000 is a mirror image of the first couplingassembly 900, wherein a component of the second coupling assembly havinga reference number of 10XX corresponds to a component from the firstcoupling assembly 900 having a reference number of 9XX. The firstcoupling assembly 900 will be described herein with the understandingthat unless otherwise noted, the second coupling assembly 000 is amirror image of the first coupling assembly.

As best shown in FIG. 9, the first coupling assembly 900 includes afirst arm 916 coupled to a V-shaped forward band portion 922. A firstend 926 of the forward band portion 922 is secured to an occlusalportion of one or more teeth using adhesive cement or other suitablemeans. A second end 928 of the forward band portion 922 is secured to alingual portion of one or more teeth using adhesive cement or othersuitable means. The first coupling assembly also includes a second arm918 coupled to a V-shaped rear band portion 920. Similar to the forwardband portion 922, the rear band portion 920 includes a first end 930 anda second end 932 secured to the lingual and occlusal portions,respectively, of one or more teeth by adhesive cement or other suitablemeans.

Referring now to FIG. 10, the end of the first arm 916 is hollow, withan inner aperture sized and configured to slidably receive the secondarm 918. In the illustrated embodiment, the aperture has a starburstcross-section that corresponds to the outer surface of the second arm918. In this manner, the rotational position of the first arm 916relative to the second arm 918 can be selectively controlled. It will beappreciated that the shape of the aperture of the first arm 916 and thecorresponding outer surface of the second arm 918 can be triangular,square, or any other shape that will resist rotation between the arms.Further the shape of the outer surface of the first arm 916 can also betriangular, square, or any other shape that will resist rotation betweenthe first arm and the base 902 of the coupling assembly 900.

The arms 916 and 918 are secured to the screw assembly 60 between lowerclamping element 904 and upper clamping element 906. Fasteners 912 and914 secure the clamping elements together to retain the second armwithin the first arm and to secure the coupling assembly 900 to thescrew assembly. The disclosed clamping configuration allows for theposition of the arms 916 and 918 relative to the screw assembly 60 to beselectively adjustable. This adjustability, combined with theadjustability of the arms 916 and 918 relative to each other, allows forthe position of the forward and rear band portions 922 and 920 to beeasily adjusted to fit the mouth of the patient.

Referring to FIGS. 11 and 12, a fourth alternate embodiment in the formof a removable palatal distractor 1100 is shown. The distractor 1100includes a first palatal plate 1100 coupled to a second palatal plate1150 by the previously described screw assembly. In the illustratedembodiment, the second palatal plate 1150 is a mirror image of the firstpalatal plate 1100, wherein a component of the second palatal platehaving a reference number of 115X corresponds to a component from thefirst palatal plate 1100 having a reference number of 111X. The firstpalatal plate 1100 will be described herein with the understanding thatunless otherwise noted, the second palatal plate 1150 is a mirror imageof the first palatal plate.

The first palatal plate 1100 is formed of acrylic or other suitablematerial and is preferably formed from a mold of the patient's maxillarydental arch. A plurality of posts 1114 and 1116 are molded into thepalatal plate 1100 and extend therefrom to engage the patient's teethwhen distractor 1100 is installed. The first palatal plate also includesfirst and second elongate aligning arms 1112 and 1118, respectively,extending from a forward portion of the palatal plate 1110. The firstaligning arm 1112 IS configured such that when the distractor 1100 isinstalled, the first aligning arm IS positioned adjacent to the labialportion of one or more anterior teeth. The second aligning arm 1118 isconfigured such that when the distractor 1100 is installed, the secondaligning arm is positioned adjacent to the lingual portion of one ormore anterior teeth.

Referring to FIG. 12, with the distractor 1100 installed, the posteriorteeth disposed between the sides of the palatal plates 1110 and 1150 andthe posts 1114, 1116, 1154, and 1156 extending therefrom. The anteriorteeth are positioned between the first aligning arms 1112 and 1152 andthe second aligning arms 1118 and 1158. The position of the palatalplates 1110 and 1150 relative to each other is selectively adjustableusing the screw assembly 60 a portion of which is embedded in orattached to each palatal plate. In this manner, the distractor 1100 canbe expanded or contracted, both symmetrically or asymmetrically withrespect to the front and back portions. As the distractor 1100 isexpanded and contracted, the position of the teeth relative to thedistractor is maintained by the posts and retainers. Further, incontrast to previous embodiments, the distractor 1100 is easily removedand installed by the patient.

The following is a protocol of alternate rapid maxillary expansions andslow constrictions (Alt-RMESC). The Alt-RMESC protocol is eithereffective in patients with or without cleft lip and palate. TheAlt-RMESC protocol was developed in 2003 for the growth modification andtreatment of constricted or retrusive maxilla in class I, class II, orclass III type skeletal discrepancies, not only for the growing patientswith cleft lip and palate, but also for those without cleft and also fornon-growing patients. The clinical devices and protocol are exactly thesame for both groups of patients. The devices are the differentembodiments of a dual expanding palatal distractor.

The complete Alt-RMESC protocol involves 8-10 months. The expanded spacebetween the central incisors could be saved for relieving anteriorcrowding or for compensating dental effects, such as the proclinedmaxillary incisors due to the protraction.

The HYRAX and HAAS type, fan shape expanders or even double-hingedexpanders cannot be as effective as this invention for the opening ofcircumaxillary sutures under the Alt-RMESC protocol. The key is not onlythe design of the differential nonparallel expansion capability of thedual screw appliances described here, but also the Alt-RNIESC protocolrather than the types of expander.

Several types of rapid maxillary expander have been used for the purposeof maxillary expansion. They are the HYRAX and HAAS type, fan shapeexpanders or even double-hinged expanders with two acrylic resin halves,splints, or in a hygienic design. These appliances expand and rotate themaxilla outward in a parallel or V-shaped manner.

In case of fan shape expanders or even double-hinged expanders, thecenter of rotation is located around the posterior nasal spine. Theexpansion force is distributed not only in the maxilla, but also extendsinto the circumaxillary structures. It is postulated that this entailsbone resorption behind the maxilla and consequently results in posteriordisplacement of maxilla. On the contrast, it is postulated as well thatthis entails the circumaxillary structures such as pterygpoid plates todisplace the maxilla forward. These two assumptions explain why some ofthe clinical studies on Hyrax-typed expanders reported an anteriordisplacement of maxilla, while some others reported no significantdisplacement or even a posterior displacement of maxilla. The posteriordisplacement of maxilla compromises the maxillary protraction in ClassIII patients.

Embodiments of the dual rapid maxillary expander described herein aredeveloped for incremental, differential, nonparallel expansion andconstriction of anterior and posterior maxilla. In some embodiments, itsconfiguration has two identical rotation hinges. It includes a jackscrewin the center in front and the back. It expands and rotates each half ofthe maxilla outward and inward, sequentially in nonparallel incrementsthrough the two independent hinges of rotation, one in front and theother in the back. This model of expansion entails forward or backwardrotation of maxilla with a lower chance of bone resorption behind themaxillary tuberosities, and this has been verified in an experimentalstudy in cats, that the double-hinged expander significantly displacedthe maxilla more anteriorly than the Hyrax expander. Therefore, in termsof the anterior displacement of maxilla, a dual-maxillary expander issuperior to the other types of expander for the treatment of ahypoplastic or transversely deficient maxilla in growing or non-growingpatients.

The inter-maxillary suture is an osteogenic and osteolytic tissue thatallowed for a certain degree of expansion and constriction. Within thebiological and physiological limitations, expansion of a suture leads tobone formation, and constriction leads to bone resorption. Thisphenomenon also has been referred as the sutural distractionosteogenesis and osteolysis, respectively, that resembles the callusdistraction osteogenesis or osteolysis in the long bone. For the callusdistraction osteogenesis in long bone, it has been revealed that theoptimal (biological and physiological) rate of distraction is 1 mm/day,so in this protocol it is recommended between 0.5 to maximum 1 mm ofrapid expansion in front every day and in the posterior every other dayfor 1 first week and between 0.5 to maximum 1 mm of rapid expansion inback every day and in the front every other day for second week, thenstop It also has been considered that 1 mm/day is the biological,physiological, and optimal rate for rapid maxillary suture expansion.The optimal rate of expansion or distraction for any osteogenetictissue, such as suture or callus, is 1 mm/day. To encourage the properbiologic bone formation at the expanded sutural parts, it is recommendedin the protocol that a rest period of two months for full ossificationof the distracted piece and complete conversion of the expanded softtissue to boney tissues. The following constriction of the maxillaryposterior teeth is at the rate of one turn twice per week, equaling to0.5 mm constriction of the posterior teeth per week until the upperposterior teeth get close to the lower posterior teeth. This protocolwill reduce the chance of bone resorption as result of osteolysis at thesutural tissue, which can impact negatively the transverse dimension ofthe nasal cavity. The daily expansion of a suture should be biologicallyand physiologically confined within less than 1 mm/day or constrictionof less than 0.5 mm per week. At the completion of the constriction,sequentially the maxilla can have two or three Alt-RMESC until theproper nasal cavity expansion is acquired. In each rapid phase ofexpansion, the nasal cavity and related bones including; maxillary,palatine, zygomatic bones will expand equal or close to equal of thetotal maxillary expansion. The slow constriction eliminates theconstriction of the nasal cavity. This incremental expansion willeventually provide ideal expansion of the nasal cavity and facial widthin maxillary and inter-zygomatic area more efficiently than any existingprotocols.

FIG. 14 shows an exemplary method of applying an Alt-RMESC protocol witha total treatment period of 8-10 months, including 3-4 repetitions insequence. The process starts at step 2001 and proceeds to step 2002,wherein rapid maxillary expansion is provided for approximately 2 weeks.During the first week, rapid maxillary expansion is achieved by turningthe front screw turns 2-3 times daily to provide a maximum extension of1 mm every day. In addition, during this first week, the back screw isturned 2-3 times every other day to loosen the maxillary suture likeunzipping the suture, starting in front then continuing toward the back.During the second week, rapid maxillary expansion is achieved by turningthe back screw 2-3 times daily to provide a maximum extension of 1 mmevery day. During this second week, the front screw is turned 2-3 timesevery other day to make the expansion equal in back and front if needed.

The process proceeds to step 2003, during which no expansion is providedfor approximately 2 months to allow the effective ossification of theexpanded soft tissue.

Next, in step 2004, at least two months of slow constriction areachieved by one turn, twice per week, up to a maximum of 0.5 mm dentalconstriction per week. Constriction is provided until the upperposterior teeth come close to the lower posterior teeth.

In step 2005 rapid maxillary expansion is again provided forapproximately 2 weeks. During the first week, rapid maxillary expansionis achieved by turning the front screw turns 2-3 times daily to providea maximum extension of 1 mm every day. In addition, during this firstweek, the back screw is turned 2-3 times every other day to loosen themaxillary suture like unzipping the suture, starting in front thencontinuing toward the back. During the second week, rapid maxillaryexpansion is achieved by turning the back screw 2-3 times daily toprovide a maximum extension of 1 mm every day. During this second week,the front screw is turned 2-3 times every other day to make theexpansion equal in back and front if needed.

Next, in step 2006, no expansion or constriction is provided for atleast 2 months in order to allow the effective ossification of theexpanded soft tissue. In step 2007, a frontal view cephalometricradiographic assessment of the nasal cavity expansion after each rapidexpansion period is performed.

In step 2008, the protocol is continued until the desireddisarticulation of the circumaxillary sutures and expansion of the nasalcavity is acquired for sufficient improvement of the upper airway.

Next, in steps 2009 and 2010, the distractor is removed and 1 month isallowed to pass to enable the disappearance of possible nasomaxillaryinflammation caused by Alt-RMESC.

Finally, in step 2011, an in-lab sleep study assessment is conducted toevaluate the improvement of the airway.

In an alternative protocol, especially in adult patients, the treatmentstarts by installation of the upper bonded dual expander device as FIG.9, then patient will have surgical osteotomy in midpalatal area or asLefort 1. In one embodiment, the apparatus is activated for expansionbeginning 3 to 7 days after osteotomy, depending on the age of patient,at a rate of two to four times daily, every 6 to 12 hours, at a rate of0.5 to 1 mm per day. This expansion can be in parallel or non-parallelway depending on the requirement of the shape of the opposing dentalarch form. In certain cases which require counterclockwise rotation ofthe maxillary structures, by use of vertical elastics anchored to thelower teeth or temporary implants inserted in the body of mandible, thedistraction can be directed vertically in combination of transversely.The transverse and/or vertical expansion of the apparatus is continueduntil the desired over-expansion is accomplished, then stabilized for30-60 days after distraction.

In another alternative protocol, the stem cells of the patient can becollected from the blood or bone marrow or in combination with plateletrich plasma injected in the area of distracted bone and surgical site toenhance or facilitate the amount of expansion and shorten the period ofstabilization. Periodic panoramic or cone beam computed tomography takenat monthly intervals indicates that the distraction gaps are bridged bynew bony regenerate.

This stage of protocol provides significant expansion in the body of themaxilla at the base of the tongue for proper airway expansion. It alsowidens the maxillary area to overcome narrow maxillary dentoalveolarstructures. The over-expansion at the alveolar area enables the nextstage of protocol for improvement of recessed gingival areas. Theapparatus is activated by slow reverse contraction of 2 turns weekly toconstrict the posterior teeth to the final desired width and embed theteeth back to the newly-formed alveolar bone. In the next stage, anon-extraction orthodontic alignment of the maxillary teeth can beaccomplished. This technique and apparatus provide an efficienttechnique to avoid extraction of the teeth for relieving crowding andcan develop an adequate recipient site for insertion of implants toreplace the missing teeth and as simple surgical alternatives, can be anexcellent adjunct for treatment of obstructive sleep apnea. It can beutilized for correction of midface deformities caused by maxillarytransverse, vertical and sagittal deficiencies.

While various embodiments have been illustrated and described, it willbe appreciated that various changes can be made therein withoutdeparting from the spirit and scope of the claimed subject matter.

1. An orthodontic distractor capable of expansion or constriction toadjust the position of one or more of a patient's upper teeth, jaws,oral cavity and airway, the distractor comprising: an adjustableassembly, comprising: a first rod and a second rod, each of the firstand second rods having a first end and a second end, wherein each of thefirst and second rods is couplable to upper teeth of a patient; amechanism joining the first and second rods and permitting the firstends of the first and second rods to be pushed apart or pulled togetherindependent of the second ends and which permits the second ends of thefirst and second rods to be pushed apart or pulled together independentof the first ends; a first coupling assembly configured to couple thefirst rod to a bicuspid and a molar tooth of a patient; a secondcoupling assembly configured to couple the second rod to a bicuspid anda molar tooth of a patient; and wherein the first coupling assemblyincludes first extension arms attached to the first rod so as to permitadjustment of a vertical angle between said first rod and said firstextension arms, and the second coupling assembly comprises secondextension arms coupled to the second rod, so as to permit adjustment ofa vertical angle between said first rod and said first extension arms.2. An orthodontic distractor capable of expansion or constriction toadjust the position of one or more of a patient's upper, lower teeth,jaws, oral cavity and airway, the distractor comprising: a screwassembly, comprising: a first rod and a second rod, each of the firstand second rods having a first end and a second end, wherein each of thefirst and second rods is couplable to one or more of upper teeth andpalatal bones of a patient; a plurality of rotatable head members, eachof which comprises a threaded hole, wherein the plurality of rotatablehead members comprises a first rotatable head member connected to thefirst end of the first rod, a second rotatable head member connected tothe first end of the second rod, a third rotatable head member connectedto the second end of the first rod, and a fourth rotatable head memberconnected to the second end of the second rod, wherein the threadedholes of the first and second rotatable head members are of oppositehand, and wherein the threaded holes of the third and fourth rotatablehead members are of opposite hand; a first twin screw having threadedends of opposite hand, wherein the threaded ends of the first twin screware configured to engage the threaded holes of the first and secondrotatable head members such that rotation of the first twin screw causesthe first and second rotatable head members and the first ends of thefirst and second rods to either move together or move apart; and asecond twin screw having threaded ends of opposite hand, wherein thethreaded ends of the second twin screw are configured to engage thethreaded holes of the third and fourth rotatable head members such thatrotation of the second twin screw causes the third and fourth rotatablehead members and the second ends of the first and second rods to eithermove together or move apart; a first coupling assembly configured tocouple the first rod to one or more of upper teeth and palatal bones ofa patient a stabilizing member placed between said first and second rodand extending between and engaged to said first twin screw and saidsecond twin screw so as to constrict movement of both said first twinscrew and said second twin screw and maintain said first and second twinscrews in parallel orientation.
 3. The orthodontic distractor of claim2, wherein said stabilizer defines a first pair of apertures, throughwhich passes the first twin screw, and a second pair of apertures,through which passes the second twin screw.
 4. The orthodonticdistractor of claim 2, wherein said stabilizer defines a first pair ofsaddles, through which passes the first twin screw, and a second pair ofsaddles, through which passes the second twin screw.